This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the onset and progression of left ventricle dysfunction in children with DMD. Multiple studies show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved for patients in whom heart failure is not adequately treated or where side effects preclude the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse. Considering that both skeletal and cardiac muscles are major contributors of the disability of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need consideration as the drug of choice for the cardiomyopathic DMD patient.

Participants will have a baseline visit and then followed every four months for the duration study, anticipated for a total of 2 years.

Secondary Outcome Measures:

Skeletal muscle strength [ Time Frame: Every 12 months for 2 years ] [ Designated as safety issue: No ]

Muscle strength will be measured by hand held dynamometer. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits.

Skeletal Muscle function [ Time Frame: Every 12 months for 2 years ] [ Designated as safety issue: No ]

Skeletal muscle function will be measured by Brooke Upper Extremity Functional Rating Scale, Nine-Hole-Peg test, and 6-minute walk test (6MWT). Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits.

Other Outcome Measures:

Pulmonary function testing [ Time Frame: Every 12 months for 2 years ] [ Designated as safety issue: No ]

Forced vital capacity (FVC) will be measured using a spirometer. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits.

Changes in activities of daily living [ Time Frame: Every 12 months for 2 years ] [ Designated as safety issue: No ]

Measured using the Egen Klassification (EK) Scale. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits.

Health related quality of life [ Time Frame: Every 12 months for 2 years ] [ Designated as safety issue: No ]

Measured using the PedsQL. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982695

Locations

United States, California

University of California Davis

Davis, California, United States

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States

United States, Minnesota

University of Minnesota

St. Paul, Minnesota, United States

United States, Missouri

St. Louis Children's Hospital

St. Louise, Missouri, United States

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States

Sponsors and Collaborators

Nationwide Children's Hospital

Children's Hospital Boston

University of California, Davis

Unverisity of Kansas Medical Center

University of Minnesota - Clinical and Translational Science Institute